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Linear growth response to recombinant human growth hormone in children with growth hormone deficiency
1Department of Medicine, Army 804 General Hospital, Taipei, Taiwan, R.O.C.
Insights
Recombinant human growth hormone (rhGH) therapy effectively and safely treats children with growth hormone deficiency (GHD). Three tested rhGH formulations showed comparable efficacy in improving growth parameters and bone age in prepubertal children.
Area of Science:
- Pediatric Endocrinology
- Biotechnology
- Clinical Trials
Background:
- Growth hormone deficiency (GHD) in children impacts growth and development.
- Recombinant human growth hormone (rhGH) is a key therapeutic agent for GHD.
- Evaluating different rhGH formulations is crucial for optimizing treatment.
Purpose of the Study:
- To assess the efficacy, safety, and immunogenicity of three recombinant human growth hormone (rhGH) preparations.
- To compare the therapeutic outcomes of Saizen, Genotropin, and Humatrope in children with GHD.
- To determine the optimal rhGH treatment for prepubertal GHD children.
Main Methods:
- A 12-month clinical trial involving 15 prepubertal children diagnosed with GHD.
- Patients were divided into three groups of five, each receiving a different rhGH formulation (Saizen, Genotropin, or Humatrope).
- Key efficacy measures included changes in bone age (BA), height velocity (HV), and height standard deviation score (SDS).
Main Results:
- All three rhGH formulations significantly increased height velocity and improved bone age and height SDS in GHD children.
- Saizen, Genotropin, and Humatrope demonstrated comparable efficacy, with no significant differences in growth outcomes.
- Adverse events were minimal, with only two patients developing low-titer anti-rhGH antibodies and one experiencing subclinical hypothyroidism. No significant side effects were noted in the remaining patients.
Conclusions:
- The three tested rhGH products (Saizen, Genotropin, Humatrope) exhibit comparable efficacy and safety profiles in treating prepubertal GHD.
- rhGH therapy is a safe and effective treatment for prepubertal children with GHD.
- Recombinant DNA technology-produced GH formulations provide significant growth benefits without major safety concerns.
Background:
This study was to evaluate the efficacy, safety and immunogenicity of recombinant human growth hormone (rhGH) in treatment of children with growth hormone deficiency (GHD).
Methods:
We selected 15 children with GHD for a 12-month clinical trial and separated them into three groups with each 5 patients receiving one of the 3 tested rhGH (Saizen by Serono, Aubonne, Switzerland; Genotropin by KabiVitrum, Stockholm, Sweden and Humatrope by Eli Lilly, Indianapolis, USA).
Results:
In Saizen group, 3 boys and 2 girls with a mean chronological age (CA) of 10.6 +/- 1.7 yrs and bone age (BA) of 6.7 +/- 1.2 yrs, at dose of 0.2 IU/kg sc tiw, gained an average BA of 2.1 +/- 1.3 yrs. The mean height velocity (HV) increased from 3.7 +/- 1.2 to 11.1 +/- 3.3 cm/yr. The height standard deviation score (SDS) increased from -4.2 +/- 3.1 to -3.1 +/- 2.9. In Genotropin group, 2 boys and 3 girls with a mean CA of 9.2 +/- 2.3 yrs and BA of 5.6 +/- 2.1 yrs, at dose of 0.1 IU/kg sc qd, gained an average BA of 0.8 +/- 0.2 yr. The mean HV increased from 3.4 +/- 0.7 to 11.3 +/- 2.0 cm/yr. The height SDS increased from -4.0 +/- 0.5 to -2.7 +/- 0.7. In Humatrope group, 4 boys and 1 girl with a mean CA of 10.3 +/- 3.5 yrs and BA of 5.8 +/- 2.9 yrs, at dose of 0.1 IU/kg sc qd, gained at average BA of 0.8 +/- 0.7 yr. The mean HV increased from 4.0 +/- 1.3 to 9.4 +/- 1.9 cm2yr, and the height SDS increased from -2.9 +/- 0.7 to -2.2 +/- 1.0. Very low titers of anti-rhGH antibodies were noted only in two patients, one in Saizen group (titer = 1:10) and the other in Genotropin group (titer = 1:6). Their HV was not affected (Saizen: 13.3 cm/yr, Genotropin: 11.2 cm/yr). One patient evolved subclinical hypothyroidism whereas no side effect at all was noted in the rest of patients.
Conclusions:
Three tested GH (Saizen, Genotropin, Humatrope) produced by recombinant DNA technology appear to make no significant difference in this clinical trial, and rhGH therapy is an effective and safe treatment for prepubertal GHD children.